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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Imaging Device has Potential to Display Other Patients' Images, Says Company in Recall Notice

When undergoing a medical imaging procedure, patients expect some measure of clarity. If for instance, a patient goes in for an angiography, they expect their doctor to be able to use the image to diagnose any cardiac problems that might be present or other renal problems. But as one recent recall shows, patients could be none the wiser if a medical device accidentally displays the wrong information from an imaging procedure.

The device in question is Toshiba's Infinix-I X-Ray System, a radiographic and fluoroscopic X-ray system used in diagnostic and angiographic procedures. The device is touted by the company as one that enables physicians to perform a range of interventional procedures, and most notably, has "the ability to transition between cardiac and peripheral work seamlessly."

"When excellence means saving lives, the right lab is absolutely vital," it says on its website. "Unlike other imaging systems, the cardiovascular lab is literally an extension of the clinician's eyes and hands. As such, it must provide access, coverage, image quality and workflow efficiency that fluidly enhances a clinician's performance."

But as a Class II recall notice from the company shows, if the device is an extension of a clinician's hands, they may as well be hallucinating.

The problem, according to its 25 March 2013 recall notice, is that the device has an infrequent tendency to either lose or incorrectly display images, potentially putting patients at risk.

"When using the 'F-Rec' fluoroscopy image acquisition recording option in the 'manual mode' an infrequent software error may cause images from another study to be displayed on the monitor," the company explained. "The acquired images may be lost requiring additional image acquisitions to be performed."

The potential for that mix-up has led the company to issue an "urgent" medical device correction letter to its customers, though its notice does not indicate whether any work-arounds exist in the interim.

The company's recall affects 95 of its devices manufactured between 2003 and 2010.